News
2022.02.18
The clinical trial on a first-in-class new drug for the treatment of rare diseases currently being developed by Hanmi Pharmaceutical has been selected as the cover article by an SCI journal.
On February 18, Hanmi Pharm announced that the clinical study on LAPSGlucagon Analog (HM15136; hereinafter referred to as “LAPSGlucagon Analog”), which is being developed as a first-in-class drug for the treatment of congenital hyperinsulinemia, will be published in the March issue of the SCI journal, “Diabetes, Obesity and Metabolism (DOM).”
DOM selected the study as the cover article in consideration of the potential and innovativeness LAPSGlucagon Analog and featured an image of the molecular structure on the cover.
LAPSGlucagon Analog is the world’s first long-acting glucagon analog to be administered once a week that is currently under development. The half-life of glucagon, which promotes glucose synthesis in the body, has been drastically improved to treat rare diseases such as congenital hyperinsulinemia and hypoglycemia.
The paper set to be published is based on a study carried out to evaluate the safety, tolerability, and pharmacokinetics of LAPSGlucagon Analog at five difference doses in 56 healthy subjects, in which the excellent effectiveness and safety of single-dose, subcutaneous injections of the investigational drug were confirmed.
According to the study, LAPSGlucagon Analog significantly increases fasting blood sugar levels for up to 17 days. The continued elevated levels of blood sugar show the potential for the administration cycle to be extended to two weeks from a weekly administration, which is the development goal of Hanmi Pharmaceutical.
No serious side effects were reported for any of the doses, indicating excellent safety and tolerability, and a favorable cardiovascular safety profile was also observed. Hanmi Pharm is currently conducting an additional Phase 2 clinical study to confirm the potential benefits of a LAPSGlucagon Analog in patients with rare diseases associated with hypoglycemia.
In recognition of its potential and innovativeness, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) designated LAPSGlucagon Analog as an orphan drug for congenital hyperinsulinemia in 2018. Then, in 2020, it was designated as an orphan drug for insulin autoimmune syndrome by the EMA and as an orphan drug for rare pediatric disease (RPD) by the FDA. The Ministry of Food and Drug Safety of Korea designated it as a development-stage orphan drug in the development stage in 2019.
LAPSGlucagon Analog was selected for the National New Drug Development Project by the Korea Drug Development Fund last November, and national research funding will be provided over the course of 28 months for global clinical trials and commercialization research.
“Congenital hyperinsulinemia, a rare disease occurring in about 1 in 50,000 births, is a life-threatening disease in severe cases, but there aren’t any approved treatments for it at present,” said Hanmi Pharm President Kwon Se-chang, who added, “The innovativeness of LAPSGlucagon Analog has caught global attention, and we will do our best to commercialize it as soon as possible so that it can dramatically improve the quality of life of patients suffering [from congenital hyperinsulinemia).”
Source: Cheongnyeon Ilbo (Youth Daily)